scope:

This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes.

This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range.

The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices (e.g. ventilators, anaesthesia workstations, etc.).